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Last Updated: January 20, 2021

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GLAXOSMITHKLINE Company Profile

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Drugs and US Patents for GLAXOSMITHKLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes 9,333,310   Start Trial Y   Start Trial
Glaxosmithkline POTIGA ezogabine TABLET;ORAL 022345-003 Jun 10, 2011 DISCN Yes No   Start Trial   Start Trial
Glaxosmithkline STELAZINE trifluoperazine hydrochloride TABLET;ORAL 011552-003 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes 7,776,895   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for GLAXOSMITHKLINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-003 Jun 1, 1995 6,368,627*PED   Start Trial
Glaxosmithkline AGENERASE amprenavir SOLUTION;ORAL 021039-001 Apr 15, 1999 5,723,490   Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-001 Oct 4, 1996 5,427,798   Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996 5,427,798   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 2 mg ➤ Subscribe 2008-10-14
➤ Subscribe Gum 4 mg ➤ Subscribe 2013-01-22
➤ Subscribe Extended-release Tablets 3 mg ➤ Subscribe 2009-01-08
➤ Subscribe Injection 6 mg/0.5 mL, 0.5 mL (prefilled syringes) ➤ Subscribe 2006-05-09
➤ Subscribe Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg ➤ Subscribe 2004-12-22
➤ Subscribe Tablets 250 mg/100 mg ➤ Subscribe 2009-04-03
➤ Subscribe Capsules 60 mg ➤ Subscribe 2010-09-08
➤ Subscribe Extended-release Capsules 225 mg and 425 mg ➤ Subscribe 2006-10-11
➤ Subscribe Extended-release Tablets 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg ➤ Subscribe 2014-02-12
➤ Subscribe Capsules 200 mg/38 mg ➤ Subscribe 2016-02-16
➤ Subscribe Extended-release Tablets 8 mg ➤ Subscribe 2008-11-03
➤ Subscribe Capsule 0.5 mg/0.4 mg ➤ Subscribe 2010-10-26
➤ Subscribe Extended-release Tablets 12 mg ➤ Subscribe 2009-02-05
➤ Subscribe Gum 2 mg ➤ Subscribe 2013-01-22
➤ Subscribe Extended-release Tablets 6 mg ➤ Subscribe 2009-07-22
➤ Subscribe Injection 6 mg/0.5 mL, 0.5 mL vials ➤ Subscribe 2004-10-25
➤ Subscribe Orally Disintegrating Tablets 25 mg, 50 mg, 100 mg, and 200 mg ➤ Subscribe 2009-12-21
➤ Subscribe Tablets 100 mg ➤ Subscribe 2007-10-31
➤ Subscribe Tablets 3 mg, 4 mg and 5 mg ➤ Subscribe 2005-02-04
➤ Subscribe Tablets 62.5 mg/25 mg ➤ Subscribe 2010-09-14
➤ Subscribe Extended-release Capsules 325 mg ➤ Subscribe 2006-11-07
➤ Subscribe Oral Suspension 750 mg/5 mL ➤ Subscribe 2009-10-20
➤ Subscribe Capsules 200 mg/30 mg ➤ Subscribe 2004-12-27
➤ Subscribe Extended-release Tablets 4 mg ➤ Subscribe 2008-10-31
➤ Subscribe Capsules 0.5 mg ➤ Subscribe 2007-10-29
➤ Subscribe Extended-release Tablets 3 mg ➤ Subscribe 2009-01-08
➤ Subscribe Tablets 150 mg ➤ Subscribe 2007-10-30

Supplementary Protection Certificates for GLAXOSMITHKLINE Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0719278 03C0030 France   Start Trial PRODUCT NAME: DUTASTERIDE; NAT. REGISTRATION NO/DATE: NL 28 131 20030327; FIRST REGISTRATION: SE - 17 871 20020719
1740177 122014000096 Germany   Start Trial PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
2316456 132017000142109 Italy   Start Trial PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
0933372 13/2008 Austria   Start Trial PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Dow
Moodys
Boehringer Ingelheim
Johnson and Johnson
AstraZeneca
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.